In Part 1 of our “Ftag of the Week” for F605, we reviewed the regulation itself and outlined some key definitions. In this part of our review, we will review one more important definition – indication for use – and look at how it’s applied in this regulation.
What’s Indication for Use?
Indication for use, for the purposes for F605, is defined as the identified, documented clinical rationale for administering a medication that is:
- Based on an assessment of the resident’s condition and therapeutic goals and
- Consistent with manufacturer’s recommendations and/or clinical practice guidelines/ standards of practice, medication references, clinical studies and/or evidence based, published reviews.
Per the Interpretive Guidance in Appendix PP, the indication for use for any medication ordered for a resident must be identified and documented in the record. Why it’s important related to the idea of a chemical restraint is that if a medication restricts a resident’s movement or cognition or sedates/ subdues the resident and is not an accepted standard of practice for the resident’s medical or psychiatric condition, which could be considered a form of restraint.
Here’s a worst-case scenario citation to helps paint a picture of why it’s important to ensure the rationale for use is appropriate:
Complaint Survey Citation – F605 S/S:J (Immediate Jeopardy)
A facility was placed in Immediate Jeopardy after it was identified that it failed to ensure chemical restraints were not used for a resident who was administered Morphine Sulfate without clinical indication that a resident was experiencing pain and for the purpose of treating the resident’s behaviors of anxiety, restlessness and agitation. The resident was transferred to the emergency room lethargic, minimally responsive, hypoxic, hypotensive, with bradypnea and pinpoint pupils due to suspected overmedication.
The resident’s pertinent diagnoses included dementia with behavioral disturbance, autistic disorder, anxiety disorder, bipolar II disorder, unspecified signs and symptoms involving cognitive functions and awareness and insomnia, with a history of psychiatric hospitalizations. Review of the resident’s medical record found Progress Notes written by the DON where she spoke with the resident’s guardian about the resident’s decline and increased behaviors and restlessness. The guardian refused any medications despite the DON telling her that the facility would not be able to meet the resident’s needs. The DON wrote a Progress Note indicating that the facility is having issues working with the guardian, who does not want the resident to have medications changed or increased. She also stated that she left a voicemail for the guardian to let her know that the resident’s Risperdal was being increased in hopes of making the resident more comfortable as she was still extremely restless. This was obviously in contrast to the prior part of the note about the guardian’s permission.
The DON spoke with the guardian later to get her permission to offer “comfort medication” for the resident, and the guardian agreed to the lowest dose of Morphine, to which the resident did not respond. The resident was ordered Roxanol 20mg/ml with directions for 0.25ml (5mg) q2hr prn. There was no clinical indication in the order for the use of this medication.
The surveyor reviewed the FDA prescribing information for morphine sulfate, which stated it was the management of pain not responsive to non-narcotic analgesics. Further review of the medical record found that despite staff stating the resident was continuously throwing herself on the ground, there was no documentation of a root cause analysis for the resident’s increased behaviors. The facility did not conduct a physical assessment, pain assessment, lab/diagnostic testing, or check to see if the resident had a UTI.
Guess what? Of course, when the resident was transferred to the ER, she was diagnosed with an acute UTI and c-diff, which likely contributed to her behaviors. Interviews with multiple staff, including Administration and Nursing Administration validated that the facility did not complete any assessments of the resident to determine if she was experiencing pain, and that the facility lacked enough staff to keep the resident on 1:1 for her safety. The facility was also unable to provide documentation evidence that the resident was terminally ill and thus a candidate for hospice, which the DON attempted on multiple occasions to have the guardian agree to so the resident could be provided “comfort” for her pain. Key to the IJ at F605 is that the resident had no documentation of pain on admission, on any MDS assessment or in the medical record that would make it appropriate for morphine to be ordered and administered to her.
Obviously, a lot of things went wrong with this resident’s care, but it reinforces the reminder that the facility is accountable for ensuring that a resident is appropriate assessed, there is documentation of medical symptom(s) being treated, and the IDT developed an individualized plan of care for each resident. It’s also important to be able to show evidence of what else has been attempted – and failed – prior to use other meds, such as those that have been designated potentially inappropriate medications for use in older adults.
Use of a Less Restrictive Alternative
In addition to ensuring there is appropriate indication for use, providers also need to ensure that even if use of a medication follows accepted standards of practice, the least restrictive medication option is used. If a less restrictive alternative medication is not attempted, this could be considered a chemical restraint since there was a different medication available that could have met the resident’s treatment needs.
Use to Treat a Medical Symptom
Just as it’s important to ensure that the least restrictive medication is used, if warranted, it’s also important for to remember that a medication could be considered a chemical restraint if the medical symptom that has been justifying use of the medication has subsided.
Before a medication is used to treat a medical symptom, there should be evidence in the medical record about whether the IDT has identified and addressed – to the extent possible – underlying causes of distressed behaviors, either before or while treating a medical symptom. SOM Appendix PP provides several common examples of potential underlying causes for expressions/ indications of distress. These include delirium, pain, presence of an adverse consequence related to the individual’s current medication regimen or environmental factors.
Complaint Citation – F605 S/S: E
A facility was cited for failure to ensure one resident was free from chemical restraints by not determining the underlying cause of the resident’s increased agitation and not monitoring the adverse effects of four medications that affect the CNS which were prescribed to the resident. The resident, who had diagnoses of Alzheimer’s, MDD, and ESRD had orders for Ativan, Restoril, Benadryl, and Effexor, all of which were routinely administered. The resident’s medical record indicated events when the resident was agitated and lacked any evidence of nonpharmacological interventions prior to administering Ativan. Further review of the resident’s record found that the cumulative effect of the medications contributed to the resident experiencing three unwitnessed falls and oxygen desaturation (68%), which was evident when the resident told staff she could not breathe. The resident was transferred to the hospital and expired due to acute respiratory failure.
Interviews with staff found that no one had attempted to contact the resident’s caregivers in the community to determine what triggered her agitation or how to manage her behaviors when she became agitated. The Director of Nursing stated that the resident’s baseline was agitation due to dementia and that the resident hadn’t been at the facility long enough for staff to assess the underlying cause of her agitation, which resulted in her being medicated.
In the next part of our CMSCG Blog series for F605 Right to be Free from Chemical Restraints, we will review some important information that needs to be included in the medical record to ensure there is indication for medication use and look at the risks and impacts of chemical restraints.